NCT03577522

Comparison of Two Hydroxy-apatite Coated Hip Stems

Randomized Controlled Trial Comparison of Two Hydroxy-apatite Coated Hip Stems Utilizing Radiostereometric Analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Canadian Radiostereometric Analysis Network · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

In this study, the investigators propose to randomize 80 subjects to receive either the Avenir cementless hip stem or a competing, HA-coated hip stem (Corail, DePuy-Synthes) and follow these patients for a period of 2 years post-surgery. The investigators aim to determine if the Avenir cementless hip stem has equivalent or better fixation and clinical outcomes compared to a predicate hip stem with longer clinical history.

Detailed description

This is a multi-center, randomized controlled trial of patients undergoing primary total hip arthroplasty. This study will be focused on enrollment at a single site with possible expansion to additional centers should patient enrollment occur at a slower than expected rate. Decision to expand the study to additional centers will be mutually agreed upon by both the clinical site and the study sponsor. Patients will be randomized to two study groups: 1. Zimmer Avenir cementless, HA-coated femoral hip stem with matching Trilogy IT cup; 2. DePuy-Synthes Corail cementless, HA-coated, non-collared femoral hip stem with matching Pinnacle cup Patient allocation to the study groups will occur following a randomized 4-block design.

Conditions

• Hip Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Avenir cementless hip stem	Avenir cementless hip stem vs Corail HA-coated hip stem
DEVICE	Corail HA-coated hip stem	Avenir cementless hip stem vs Corail HA-coated hip stem

Timeline

• Start date: 2018-07-19
• Primary completion: 2023-02-09
• Completion: 2024-01-30
• First posted: 2018-07-05
• Last updated: 2025-12-04

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study